Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

June 13, 2020 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

91

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL according to WHO 2016 criteria.
  2. ECOG PS 0-2
  3. Age 18-70 years old
  4. Expected survival ≥ 12 weeks
  5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
  6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
  7. Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures

Exclusion Criteria:

  1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
  2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
  3. Patients known to have varicella or herpes zoster virus infection
  4. Previous exposure to any anti-tumor therapy
  5. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma
  6. History of DVT or PE within past 12 months
  7. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
  8. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
  9. CNS or meningeal involvement
  10. Known sensitivity or allergy to investigational product
  11. Major surgery within three weeks
  12. Patients receiving organ transplantation
  13. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
  14. Presence of Grade III nervous toxicity within past two weeks
  15. Active and severe infectious diseases
  16. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
  17. In any conditions which investigator considered ineligible for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenalidomide+CHOP
Drug: Lenalidomide
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle
Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m2 d1
Drug: Doxorubicin
Doxorubicin 50 mg/m2 d1
Drug: Vincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1
Drug: Prednisolone
Prednisolone 60mg/m2 d1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum tolerated dose and dose limited toxicity
Time Frame: At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)
At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)
Overall response rate
Time Frame: 6 months
overall response rate after treated by lenalidomide-CHOP regimen
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
from the date of inclusion to date of death, irrespective of cause
2 years
Progressive free survival
Time Frame: 2 years
from date of inclusion to date of progression, relapse, or death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, M.D., Ph.D., The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 10, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-SR-429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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